Sponsor Oversight Services

Establish an oversight approach that fits your study and your team.

Silvertree helps sponsors define how they will oversee outsourced trial activities, with clear internal responsibilities and a practical process for evaluating information and following decisions through.

This service is suited to sponsors preparing a new study, changing their outsourcing model, or formalizing existing oversight practices.

Depending on your needs, support may include:

• Defining sponsor responsibilities and decision authority.
• Establishing governance and escalation pathways.
• Planning oversight activities and review frequency.
• Developing oversight plans and documentation tools.

The scope reflects your study’s risks, service provider arrangements, and internal resources.

Understand how your oversight model operates in practice.

Silvertree assesses how your sponsor oversight model is designed and how it operates across an outsourced clinical trial. The assessment identifies strengths and material gaps, with practical recommendations in order of priority.

This service is suited to sponsors reviewing an active trial or preparing for a significant development or organizational milestone.

Using representative records and sponsor interviews, the assessment examines:

• Internal responsibilities and decision authority.
• Governance and oversight of CROs and other service providers.
• How risks and performance information inform sponsor decisions.
• Issue escalation, resolution, and evidence of follow-through.

Findings provide a structured basis for deciding where to strengthen your oversight approach.

The scope is agreed during consultation. This advisory assessment uses representative evidence; it is not a comprehensive GCP audit. Implementation support is agreed separately.

Take a closer look where attention is needed.

Silvertree provides focused quality reviews of a site, vendor, process, or area of trial conduct. Each review addresses a defined question, helping sponsors assess the available evidence and determine practical next steps.

This service is suited to sponsors investigating a specific concern or seeking an independent assessment of selected trial activities.

Depending on the agreed scope, engagements may include:

• Site or vendor audits.
• Monitoring quality reviews.
• Selected trial master file reviews.
• Reviews of specific oversight processes or quality concerns.

The scope defines whether the engagement is an advisory review or a formal audit, along with the records to be examined and the expected deliverables.